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FDA Wins Right To Regulate Adult Stem-Cell Treatments

samzenpus posted more than 2 years ago | from the big-brother-cells dept.

Biotech 216

ananyo writes "A court decision on 23 July could help to tame the largely unregulated field of adult stem-cell treatments. The US District Court in Washington DC affirmed the right of the Food and Drug Administration (FDA) to regulate therapies made from a patient's own processed stem cells. The case hinged on whether the court agreed with the FDA that such stem cells are drugs. The judge concurred, upholding an injunction brought by the FDA against Regenerative Sciences, based in Broomfield, Colorado. The FDA had ordered Regenerative Sciences to stop offering 'Regenexx', its stem cell treatment for joint pain, in August 2010. As Slashdot has noted before, they are far from the only company offering unproven stem cell therapies."

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Power Tits! (-1)

Anonymous Coward | more than 2 years ago | (#40818635)

I won the right to regulate the length of my dong in your asshole!

And not a thing will be done about it (1, Interesting)

Anonymous Coward | more than 2 years ago | (#40818681)

Liberals are happy with the expansion of the government.

Conservatives are scared shitless that without this power someone might smoke something they found in their backyard.

Re:And not a thing will be done about it (0)

Anonymous Coward | more than 2 years ago | (#40818745)

And Libertarians are too busy acting smug going "I told you so" or bashing the the libs and cons than actually doing something productive

Re:And not a thing will be done about it (4, Funny)

tnk1 (899206) | more than 2 years ago | (#40818755)

And just about everyone will be pleased that they won't see an infomercial for these unproven treatments and get swindled because they can't apply critical thinking to their own purchases.

Of course, they will just change the treatment to being labelled as a homeopathic stem cell supplement and the profits will return.

Just remember! Never trust Western Medicine or Big Pharma! Trust us instead.

Re:And not a thing will be done about it (2, Insightful)

cayenne8 (626475) | more than 2 years ago | (#40818883)

Trouble is..this is gonna stop a LOT of use tx going on now with private physicians!!

I know some doctors that have been having wonderful, and in some cases amazing results with this type of treatment. And now, sadly, you will have federal bureaucrats and miles of red tape standing in the way.

I mean, it shouldn't be that bad...they are only taking YOUR own adult stem cells, and generally, injecting them into your problem areas, and allowing your own body to heal itself.....

Now? Well, the feds will bog this down, and of course, you'll somehow involve big pharma (which does have its place)....and take what is proving to be an effective, low cost tx for many diseases....and make it more costly, and harder to perform.

Re:And not a thing will be done about it (5, Funny)

Anonymous Coward | more than 2 years ago | (#40818987)

So what you're saying is - don't mess with tx.

Re:And not a thing will be done about it (4, Insightful)

gmack (197796) | more than 2 years ago | (#40819239)

Shouldn't be that bad? They are taking cells and injecting them where they don't naturally occur. That can have side effects such as cancer [wired.com] . I'm not saying it's not promising but there have been far too many wild claims about it and far too many clinics treating it as some magic cure without any regard for patient safety.

Re:And not a thing will be done about it (0)

Anonymous Coward | more than 2 years ago | (#40819695)

Hush. The groupthink on this website is that the government is always bad. Notice how you have not been upmodded, but your parent has. This comment will, of course, be completely ignored too.

Re:And not a thing will be done about it (3, Insightful)

h4rr4r (612664) | more than 2 years ago | (#40819671)

You know some doctors that are having amazing results, but can't manage to prove it in a double blind study?

You know some conmen, not doctors.

Re:And not a thing will be done about it (2)

cayenne8 (626475) | more than 2 years ago | (#40819839)

You know some doctors that are having amazing results, but can't manage to prove it in a double blind study?

Well, considering that all of these physicians I'm speakng of, have been the heads of their departments at hospitals, VAs and teaching hospitals which do a lot of research....and that these cases they're working on, ARE part of studies ongoing...sure, I think they're qualified.

Or...do you hear the word 'doctor' and automatically think of someone that is a money grubbing quack/charlatan that will do anything to a patient/sucker for a buck?

You know...most of your doctors out there, went through shit for med school, many came out with debt that would make the people complaining about undergrad college debt puke...and aren't getting rich due to all the complications of medicine these days.....and yet they still do the job they love, to help people out....and because it is interesting and ongoing human science.

Re:And not a thing will be done about it (0)

h4rr4r (612664) | more than 2 years ago | (#40819875)

Oh bullshit. I have worked in hospitals and have family that still do. Most doctors like most everyone else goes to work to make money.

They went through medical school and took on huge debts so they could make large six figure incomes, nothing more. They are getting rich, lawsuits are a drop in the bucket, less than 1% of medical expenses.

The doctors you are speaking about are impacted by this ruling anyway, they are running studies. This ruling impacts people selling unknown goods to suckers.

Re:And not a thing will be done about it (1)

icebike (68054) | more than 2 years ago | (#40819717)

Trouble is..this is gonna stop a LOT of use tx going on now with private physicians!!

I know some doctors that have been having wonderful, and in some cases amazing results with this type of treatment. And now, sadly, you will have federal bureaucrats and miles of red tape standing in the way.

Wait, you know this HOW? Because these doctors TELL you so? (chortle).

If the results are THAT good, they should be able to prove it fairly easily, right?

So no problem. It gets approved.

On the other hand, if (like way way too many) their claims are baseless, they get booted from the market before they can hoodwink people like, well, uh, you.

Re:And not a thing will be done about it (1)

cayenne8 (626475) | more than 2 years ago | (#40819867)

I worked in medical research for a number of years....associated with a major teaching university, and the work by these doctors IS research, now in private clinics. Along with published results, etc.

Why would you automatically think someone was trying to con someone?

Do you have some kind of knee-jerk, inherit distrust of anyone with the title of Dr?

Re:And not a thing will be done about it (1)

h4rr4r (612664) | more than 2 years ago | (#40819893)

Because that is what this ruling is about. It is about charlatans selling a procedure to inject some processed stem sells to cure everything.

A study, even one done by a private company is not what we are talking about. A proper study is going to be paying patients, not charging them. A proper study will not be making advertising claims about the magic of stem cells.

Re:And not a thing will be done about it (1)

Mister_Stoopid (1222674) | more than 2 years ago | (#40819943)

If the results are THAT good, they should be able to prove it fairly easily, right?

If by "fairly easily" you mean, ten years of clinical trials and hundreds of millions of dollars.

I guess I'll just have to hope I don't need any of these treatments in the next decade.

Re:And not a thing will be done about it (4, Funny)

P-niiice (1703362) | more than 2 years ago | (#40819783)

It's not that bad. You can do it yourself at home.
Get a syringe and remove some blood from yourself. Put it in a bowl. Add some deionized water, but if you don't have that, just use tap water or whatever well water you have around the house. Warm it gently on your stove until it's slightly warm, then place the blood/water mixture into a sealed vessel - if you don't have that use a mountain dew bottle with a good cap on it. Place the vessel into a centrifuge but if you don't have that use a good clothes washer on the spin setting. Remove the blood cells with the same syringe you used earlier if you don't have a clean one. Add some chemicals to seperate the stem cells from the 'regular cells'. If you don't have the real thing crush up some mentos and a pinch of baking soda and mix it in. There will be a thin layer of clear liquid to form on the surface - thos are your stem cells. Inject those cells where it hurts.

Re:And not a thing will be done about it (4, Insightful)

Baloroth (2370816) | more than 2 years ago | (#40818785)

I think almost everyone is fine with government regulating dangerous unproven medical treatments with potentially horrific side-effects.

Re:And not a thing will be done about it (3, Insightful)

Githaron (2462596) | more than 2 years ago | (#40818897)

I would think there should be government mandated transparency but the government should not decide which drugs we are allowed to take. If you are given all the known facts upfront, you should be able to make your own choice.

Re:And not a thing will be done about it (3, Insightful)

jellomizer (103300) | more than 2 years ago | (#40819179)

" If you are given all the known facts upfront, you should be able to make your own choice."

Yet people still start to smoke, tobacco. When learned about how it effects others in the area who shown not to make the choice, they still continue.

Or you have stupid parents who believe some crazy nut job and will not vaccinate their children. In fear of a 0.001% increase of an other illness, while the vaccine will have a 5% chance of saving the child's life.

Given the Fact there will be a charismatic conspiracy nut that will refute the claims, that will attract a big following.

Re:And not a thing will be done about it (1)

Githaron (2462596) | more than 2 years ago | (#40819505)

" If you are given all the known facts upfront, you should be able to make your own choice."

Yet people still start to smoke, tobacco. When learned about how it effects others in the area who shown not to make the choice, they still continue.

I am fairly sure that most medical drugs do not require you smoke them. Even if they did, I see no reason why they couldn't smoke them in private. If they deem that smoking is worth the risks, it is their choice to make, stupid decision or not.

Or you have stupid parents who believe some crazy nut job and will not vaccinate their children. In fear of a 0.001% increase of an other illness, while the vaccine will have a 5% chance of saving the child's life.

Given the Fact there will be a charismatic conspiracy nut that will refute the claims, that will attract a big following.

Yes. There are stupid people out there. There will always be stupid people out there. That said, I would rather accept the risk that some people are going to make stupid and emotional decisions than to have the government come in and make decisions for everyone.

Re:And not a thing will be done about it (1)

Bill, Shooter of Bul (629286) | more than 2 years ago | (#40819723)

Even if they did, I see no reason why they couldn't smoke them in private

Then how do you explain why people still smoke in public places?

People are stupid, which is fine, if their own stupidity only affects themselves, but when their stupidity starts affecting other people the government does have a legitimate role in stepping in to protect other people. It is very difficult to figure out where that line is in many cases.

Right now, there are tons of examples of nutrient suppliments blatently lying about their effect and contents of their suppliments. How can anyone make up their mind in this case? Shouldn't the government step in and require these companies to do proper research?

Re:And not a thing will be done about it (3, Informative)

icebike (68054) | more than 2 years ago | (#40819997)

If you are given all the known facts upfront, you should be able to make your own choice.

You need only apply this line of reasoning to other endeavors to realize it simply is not true.

Many, if not most people can not possibly make a rational decision even when presented with "all the known facts" simply because they can't
interpret the research, due to inadequate education and training.

One of the best services government supplies (other than keeping the roads patched) is preventing con artists from selling useless and dangerous products to uneducated and gullible people. This prevention costs far less than attempting to give each gullible and uneducated person a doctorate in biochemistry so that they could understand "all the known facts".

Your 14 year old daughter comes home and tells you she wants to run off with this charismatic pimp and get rich being a prostitute. You sit her down and explain "all the known facts". She rolls her eyes and runs upstairs to pack her suitcase. Do you sit idly by and say "well, she was given all the known facts upfront, it's her choice"? Most parents (perhaps not you) say no way, call the cops, because they see it as their job to protect those who can not understand, or refuse to believe "all the known facts".

Society has take the same stance with highly complex technical medical practices.

You can still find and obtain these unproven medical treatments, but society is not going to allow them to be sold in the market until they are proven. This is done because 1) there are real pimps in the world, 2) when it comes to extremely complex medical procedures a very large percentage of us are 14 years old.

Re:And not a thing will be done about it (0)

Anonymous Coward | more than 2 years ago | (#40819865)

In fear of a 0.001% increase of an other illness...

You can reduce that risk even further without a whole lot of effort. When my child was vaccinated, I checked the lot numbers of the vaccines against an adverse event reporting system spreadsheet. As with any manufactured thing, defects may arise, and it's no different with vaccines. Scanning the worksheet, I did find lot numbers with spikes of adverse event counts, and if the lot numbers had matched those about to be given to my kid, I would have asked for a different one- none ever did, but it didn't hurt to check. It irritated the hell out of some nurses, however.

Re:And not a thing will be done about it (0)

Anonymous Coward | more than 2 years ago | (#40819909)

" If you are given all the known facts upfront, you should be able to make your own choice."

Yet people still start to smoke, tobacco. When learned about how it effects others in the area who shown not to make the choice, they still continue.

Or you have stupid parents who believe some crazy nut job and will not vaccinate their children. In fear of a 0.001% increase of an other illness, while the vaccine will have a 5% chance of saving the child's life.

Given the Fact there will be a charismatic conspiracy nut that will refute the claims, that will attract a big following.

Right.

People are too stupid to make their own choices about anything. That's why nanny-government has to make all your decisions for you because we can't have people [gasp!] suffering the consequences of their own choices! You can't buy that big gulp! You can't choose to finance your own healthcare even if you're able (you get to pay for Bill Gates' healthcare!)! You can't have salt on those fries! You can't even have baby formula for your newborn!

However, you *can* get groped and searched boarding a plane, metro bus, train, or even driving down the highway 100 miles from any borders, be snatched-up by the government and imprisoned or even killed without.any due process or recourse at all, have all your communications and activities monitored, and have all your assets and property seized and not returned even if you're not convicted of or even charged with any crime, whether or not you're a US citizen, never entered the US, and didn't commit any crime in the country you're a citizen of.

Re:And not a thing will be done about it (2)

Sir_Sri (199544) | more than 2 years ago | (#40819301)

That assumes, wrongly, that you are capable of understanding the facts in context, and that you would be capable of finding alternatives and assessing facts against those. There's a reason doctors can't just prescribe you any damn thing they feel like, but rather have be to be given a list of allowed and approved medications, it is that they don't have the background even.

It's only a fairly small set of the research community who have enough of a background in both stats and other pharmaceuticals to accurately assess data from trails, and trials themselves need layers of regulation so you don't kill any more people than is absolutely necessary. And even then they take far too long to even document the risk/benefit rewards of drugs for anyone on an individual basis to wait on their work.

Also, companies would simply lie or obfuscate any facts about their drugs that are inconvenient to sales (they try and do that already to doctors and drug approval boards). The only real way to deal with that is to make sure you have a layer of experts who are supposed to have working bullshit detectors between the pharma companies and the public.

Re:And not a thing will be done about it (1)

P-niiice (1703362) | more than 2 years ago | (#40819841)

Hm yes this works perfectly with our election process so why not

Re:And not a thing will be done about it (3, Informative)

cayenne8 (626475) | more than 2 years ago | (#40818941)

I think almost everyone is fine with government regulating dangerous unproven medical treatments with potentially horrific side-effects.

Trouble is...this isn't the case here.

Most of this type of treatment..is your doctor, taking your own stem cells, isolating them, and then, injecting them back into your problem areas in a concentrated form basically.

Using your own body to treat itself....and now, well, the progress being made across the country will be halted largely, and it will now cost more money, etc.

The issue in the courts there is, that Dr's were arguing that they were using your own body to treat itself, which they are...much like a skin graft..the FDA isn't involved there. The FDA wants its hands in this...and somehow have successfully gotten the courts to say that taking your own cells out...and putting them back in...is a foreign drug being introduced into the body...and in there jurisdiction.

Sad...this one is a battle that should have been won by the doctors, as that it has been showing great progress in many areas....hope this can be appealed and overturned.

Re:And not a thing will be done about it (5, Informative)

Baloroth (2370816) | more than 2 years ago | (#40819183)

From TFA:

The court disagreed on both counts, noting that “the biological characteristics of the cells change during the process”, and that this, together with other factors, means the cells are more than “minimally manipulated”.

Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis, agrees. “It is much too simplistic to think that stem cells are removed from the body and then returned to the body without a ‘manufacturing process’ that includes risk of transmission of communicable diseases,” he says. “Maintaining the FDA’s role as watchdog and regulatory authority is imperative.”

They aren't just taking pieces from one part and injecting them into another. They are taking pieces, modifying them, and then re-injecting them. It's quite possible that a procedure that didn't modify the cells would be fine with the FDA: in fact, TFA mentions that the company in question offers 3 other processes that have much quicker turn-around which the FDA has not taken issue with (they have also not approved them, so we'll see if they decide to tackle them later as well or not).

Re:And not a thing will be done about it (1)

CptNerd (455084) | more than 2 years ago | (#40819189)

Basically it's the left side of the aisle getting revenge for not getting unlimited Federal support for embryonic stem cell research. If they're not allowed to harvest fetuses for stem cells, they won't make it easy to use adult stem cells.

Quid, meet pro quo.

Re:And not a thing will be done about it (1)

h4rr4r (612664) | more than 2 years ago | (#40819709)

No one ever harvested fetuses for stem cells. They used medical waste from abortions. No abortions were done just to get some stem cells.

Who told you this stupidity or did you make it up yourself?

Re:And not a thing will be done about it (1)

P-niiice (1703362) | more than 2 years ago | (#40819897)

And posts like this are precisely why we need to have rational people regulating medical procedures.

Re:And not a thing will be done about it (1)

Sir_Sri (199544) | more than 2 years ago | (#40819387)

injecting them back into your problem areas in a concentrated form basically.

which does what good exactly? What risks are associated with doing that? Are their risks to the procedure itself rather than just the stem cells?

Sad...this one is a battle that should have been won by the doctors,

this is a battle that should revoke medical licences for anyone who was providing such 'treatments'. If you don't have strong evidence of the risks/benefits of a procedure you shouldn't be allowed to perform it on the general public. That's basic consumer safety. Most of these 'treatments' are at the level of undergraduate guessing in a laboratory, and have no place in the general public, and anyone so reckless as to perform them should not be practicing medicine.

Stem cell therapy is very promising, but that doesn't give you the right to sell someone the chance to be a poorly thought out lab experiment. That could go real badly real fast. Offering a procedure without any proven benefit is nothing but theft.

Re:And not a thing will be done about it (1)

fufufang (2603203) | more than 2 years ago | (#40820029)

I think almost everyone is fine with government regulating dangerous unproven medical treatments with potentially horrific side-effects.

The issue in the courts there is, that Dr's were arguing that they were using your own body to treat itself, which they are...much like a skin graft..the FDA isn't involved there. The FDA wants its hands in this...and somehow have successfully gotten the courts to say that taking your own cells out...and putting them back in...is a foreign drug being introduced into the body...and in there jurisdiction.

Sad...this one is a battle that should have been won by the doctors, as that it has been showing great progress in many areas....hope this can be appealed and overturned.

You do know that the injected stem cells could easily become cancerous and kill the patient? Regulating medicine is what FDA set out to do.

http://blogs.discovermagazine.com/80beats/2009/02/18/embryonic-stem-cell-therapy-causes-cancer-in-teenage-boy/ [discovermagazine.com]

Proper regulation gets rid off snake oil, so the patient can pick those proven treatments. In this particular situation, it is more than getting rid off snake oil. It is about safety.

Re:And not a thing will be done about it (0)

roman_mir (125474) | more than 2 years ago | (#40819025)

Happy to be on the opposite side of your 'everyone'.

It's disturbing that the government has so much power and is entrenched in the minds of the people that they are happy to witness yet another powergrab and cheer for it.

Re:And not a thing will be done about it (1)

fustakrakich (1673220) | more than 2 years ago | (#40819377)

What happened? Your doctor [geniusbeauty.com] was shut down?

Re:And not a thing will be done about it (0)

roman_mir (125474) | more than 2 years ago | (#40819613)

that's market in action, weeding out idiots.

Going to a motel to get cement and glue injected in your body is not the smartest of moves, and the society shouldn't face economic destruction and individuals shouldn't have their freedoms stolen just because somebody doesn't care to check where they are going, who they are allowing to 'operate' on them.

Besides, if the FDA and other types of medical licensing wasn't required, if all these artificial barriers to entry weren't set up, there would have been more choice in the market for all these procedures as well, so prices would fall.

Sure, sure, some people would suffer. Then the names and the details would become known and anybody with half a brain cell doing a research for their own procedure would not choose to go to a motel to do cement injections.

Also this is clearly a case of fraud and bodily harm, which means it's a criminal matter.

Re:And not a thing will be done about it (2)

h4rr4r (612664) | more than 2 years ago | (#40819757)

The market in action? That is your fucking response to people being maimed? You think it is ok that some people get killed so you can save a couple bucks on cosmetic surgery?

You are one sick fuck.

Re:And not a thing will be done about it (0)

roman_mir (125474) | more than 2 years ago | (#40819805)

The market in action? That is your fucking response to people being maimed? You think it is ok that some people get killed so you can save a couple bucks on cosmetic surgery?

- obviously.

I see that your government did a fine job preventing this from happening. Oh wait, it did not. What was your retarded argument again, that government does a better job protecting people from this than the free market? How would you know, chump, you never tried free market in health care, you only had it more or less in mobile phones and computer hardware.

Re:And not a thing will be done about it (1)

h4rr4r (612664) | more than 2 years ago | (#40819935)

So because one case slips through we throw out the whole system?

As opposed to your system, were we let everyone do this and chalk up all the deaths to the hand of the free market. Yeah, I am sure the free market which can only act after the deaths from the janitor turned brain surgeon are news will do more to protect those most at risk.

Re:And not a thing will be done about it (1)

roman_mir (125474) | more than 2 years ago | (#40820021)

So because one case slips through we throw out the whole system?

- yeah, you have already threw the hole system based on a small percentage of people who had problems, you created this monstrosity of a system that is falling apart under its own weight and is taking the economy with it, you have done it as a response to a small number of cases where people had problems given a much freer market. Of-course they had other forms of solutions then, there was actual charity, doctors were working pro bono, this was the norm.

As opposed to your system, were we let everyone do this and chalk up all the deaths to the hand of the free market.

- yeah, bullshit. Under the free market the prices were falling, choices were growing, so was quality. Choices were growing and quality was growing in the health care the way the choices and quality are increasing in mobile phones today.

The relatively free market for lasik eye surgery, and definitely much freer market for veterinary care for pets shows that the free market is much more efficient, the prices are falling or at least not going up at all, which given the insane inflation caused by gov't money printing is equivalent to falling prices if the money was stable.

Re:And not a thing will be done about it (0)

Anonymous Coward | more than 2 years ago | (#40819809)

It's disturbing that the government has so much power and is entrenched in the minds of the people that they are happy to witness yet another powergrab and cheer for it.

It's only disturbing if you are weak. All great men seek power.

Power grabbing is entrenched in our collective minds and human instinct because that is the way of the jungle - survival of the fittest. The strong - the ones with power - live, the weak die.

Those with less power naturally gravitate towards those with more, either because they want to eventually take that power for themselves, or because they want to leech off of it.

People who cheer probably want to leech, and there's nothing wrong with that. There are also many people who get jealous, as they want that power for themselves. Also nothing wrong.

The only possibly wrong thing you can do is to be part of the minority who doesn't want to seek power at all. Fortunately, evolution has weeded out most of such types of people in human society. If you know somebody who doesn't want more power, pray that they never reproduce. Humanity is better off without them.

Re:And not a thing will be done about it (0)

Anonymous Coward | more than 2 years ago | (#40819187)

Why does there have to be potentially horrific side-effects for it to be regulated? If a seller is making any claim of efficacy why isn't that sufficient grounds to regulate?

Unless an independent scientific study verifies a claim's accuracy it should not be permitted to be sold making the claim.

It would eliminate ads for extenze,magnetic bands and glucosamine.

Re:And not a thing will be done about it (1)

kenorland (2691677) | more than 2 years ago | (#40819925)

I think almost everyone is fine with government regulating dangerous unproven medical treatments with potentially horrific side-effects.

That's not the problem. The problem is deciding what actually is a "dangerous unproven medical treatment with potentially horrific side-effects", and that's far from clear. A big part of our medical costs goes into attempting to ensure an unnecessary degree of safety for drugs and treatments, while problems that kill people in large numbers remain un-addressed.

So, how many thousands of dollars is it worth to you a year to have your risk of death from bad drugs reduced from 1:100000 to 1:1000000?

Re:And not a thing will be done about it (1)

h4rr4r (612664) | more than 2 years ago | (#40819967)

Bullshit, if they make any claim at all when selling a product they should be able to prove it. How many thousands of dollars are wasted every year on enzyte and magnetic bracelets, and homeopathic drowning cures?

Re:And not a thing will be done about it (2)

fufufang (2603203) | more than 2 years ago | (#40818793)

Liberals are happy with the expansion of the government.

Conservatives are scared shitless that without this power someone might smoke something they found in their backyard.

I wonder what did the conservatives say, after they discovered that thalidomide caused abnormalities in the new borns?

Re:And not a thing will be done about it (2)

demonlapin (527802) | more than 2 years ago | (#40818957)

It is possible to oppose the FDA's current mission without simultaneously wanting to abolish safety testing. The FDA is far too wrapped up in making sure things are safe and effective, which sounds like the sort of thing you would want them to do until you look at how the process actually works. The FDA as it is now turns down drugs it shouldn't. (I'm still pissed off about sugammadex.)

Re:And not a thing will be done about it (4, Interesting)

englishknnigits (1568303) | more than 2 years ago | (#40819133)

Milton Friedman addresses this:
http://www.hoover.org/multimedia/uncommon-knowledge/26936 [hoover.org]

Here is the excerpt:
ROBINSON: The Food and Drug Administration which regulates everything from the drugs that pharmaceutical companies may put on the market to the ingredients in items we purchase off the grocery store shelves. Let me give you an example- Thalidomide [FRIEDMAN Everybody's favorite example...] Well I may be leading with my chin on this one but I'm going to lead with it anyway. 50's and 60's it is marketed in Europe as a drug to help women get through the nausea that they sometimes experience during pregnancy. The Food and Drug Administration said it had been inadequately tested in the United States and forbade it to be marketed in this country with the result that thousands of children were born with horrible birth defects in Europe to mothers who had used Thalidomide but that didn't happen to American children, because the FDA had intervened and kept that drug off the market. Thank god for the FDA, right?

FRIEDMAN Wrong [ROBINSON Alright, why?] this is a case in which they did save lives, this was a good case, but suppose they are equally slow in adopting a drug which turns out to be very good and beneficial. How would you ever see the lives that are lost because of that? You're an FDA official, you have a question of whether to approve or disapprove a new drug. If you approve it and it turns out to be a bad drug like Thalidomide, you're in the soup, your name is going to be on every front page [ROBINSON cost me my job, I get hauled up to Congress to testify..] right. On the other hand if you disapprove it, but it turns out to be good, well then later on you approve it four or five years later, nobody's going to complain about the fact that you didn't approve it earlier except those greedy pharmaceutical companies that want make profits at the expense of the public, as everybody will say. So the result is that the pressure on the FDA is always to be late in approving. And there's enormous evidence that they have caused more deaths by late approvals than they have saved by early approval.

Too bad the enormous evidence isnt cited here. (1)

Anonymous Coward | more than 2 years ago | (#40819401)

The problem thats not covered is there is enormous pressure to bring products to market and make money. Without some backstop, the drug companies would end up testing their wares on the populace.
We have seen plenty of instances of companies that continue to ship products even -after- they know they are dangerous. Vinyl Chloride propellant for instance.

I am not sure if there are different "tracks" through FDA. One for cosmetics, vs another for life-saving medicine. Maybe that is a way to load the system for maximum benefit. Or if this is a new system that will replace an existing system without benefit on cost or safety it should go to the back of the line.

Re:And not a thing will be done about it (4, Interesting)

Rob Riggs (6418) | more than 2 years ago | (#40819607)

I wonder it Friedman remembers why the FDA was needed in the first place? The FDA *was a response* to an imperfect market. If it's doing what Milton says it's doing, then the FDA is doing exactly what it is supposed to do!

You know that economics as a science is fundamentally flawed when it expects that people are out to serve their best interests.

People are idiots. A person may be smart, but people are stupid and have no idea what is in their best interest. People's rational and irrational fears and impulses can be preyed upon. Marketing is all about making people make *stupid economic choices* with limited and biased information. Economics might actually work if marketing didn't exist to exploit humanity's fundamental frailties. Until then, pardon me if I don't listen to the likes of Friedman when it comes to government policy on this topic. Our must fundamental fear is fear of death. And the FDA exists to prevent that natural fear from being preyed upon by the unscrupulous.

Re:And not a thing will be done about it (2)

MickyTheIdiot (1032226) | more than 2 years ago | (#40818839)

How is this an expansion of government? The FDA regulates food and drugs. Most sane people want food and drugs to be regulated because we aren't microbiologists.

This false choice between communism and anarchy needs to end. We can't have proper debates while it's pushed like this.

Re:And not a thing will be done about it (2)

ShanghaiBill (739463) | more than 2 years ago | (#40818895)

How is this an expansion of government? The FDA regulates food and drugs.

Because stem cells are neither a food nor a drug.

Re:And not a thing will be done about it (1)

MickyTheIdiot (1032226) | more than 2 years ago | (#40818945)

Looks like it is being used as a drug to me...

Re:And not a thing will be done about it (0)

Anonymous Coward | more than 2 years ago | (#40819329)

A drug is defined by how you use it, not its contents.

Re:And not a thing will be done about it (1)

ShanghaiBill (739463) | more than 2 years ago | (#40819573)

A drug is defined by how you use it, not its contents.

Homeopaths use water as a drug. Many people use prayer as a drug. That doesn't make them drugs.

Stem cells are a normal and natural part of your body. Claiming that they are "drugs" is absurd.

Re:And not a thing will be done about it (1)

h4rr4r (612664) | more than 2 years ago | (#40819845)

They are drugs as they processed in this fashion.

Also this entire procedure should be regulated in the same way any surgical procedure should be.

Re:And not a thing will be done about it (0)

Anonymous Coward | more than 2 years ago | (#40820023)

Stem cells are a normal and natural part of your body. Claiming that they are "drugs" is absurd.

Bone marrow is a normal and natural part of my body. If I suffer a serious femur fracture and marrow leaks into my bloodstream (bone marrow embolus), I'm likely in trouble. Just because cellular structures originate in vivo, it does not follow that moving them to a different area in the body is safe.

Re:And not a thing will be done about it (1)

jellomizer (103300) | more than 2 years ago | (#40819227)

That is only FSTYPIOOYBA (Federal Stuff That You Put In Or On Your Body Administration) just doesn't have a nice ring to it.

Re:And not a thing will be done about it (0)

roman_mir (125474) | more than 2 years ago | (#40819087)

This is expansion of government, every new area and endeavour that governments ends up regulating stops progress, innovation is stifled, monopolies are created, choices are diminished and prices are raised. It is never the opposite, innovation is never encouraged by more regulations, prices never fall by more regulations, and if they are forced down by regulations in one place, then the society ends up paying through other means (like the fake insurances that governments issues, all types of loan guarantees and all types of other moral hazards, like limitation of liability, and eventual and inevitable bail outs).

People are not microbiologists, but they should be the ones deciding based on research of the market whether to buy a product, to use a service, etc., especially today, when the information is so much easier to access.

Government does not have to rate anything, by giving this power to the government you end up with terrible consequences of destruction of the market, monopolisation, huge price spikes, reduction of choices.

This is not about anarchy either, anarchy is the false choice. Bigger government is not the answer to the problem of business regulations, the free market is the answer. Government is the answer to the other question - how do politicians get more power over you, so they can sell this power to the highest and the most connected bidder?

Interesting side effects (2)

vlm (69642) | more than 2 years ago | (#40818727)

affirmed the right of the Food and Drug Administration (FDA) to regulate therapies made from a patient's own processed stem cells. The case hinged on whether the court agreed with the FDA that such stem cells are drugs.

One interesting side effect is that dialysis treatment is now a drug.

Law isn't logical, you can't p0wn it and get root permissions (unless you're a 1%er, in which case you are the law). But it is none the less weird that if dialysis was invented today, it would be considered a drug under than doctrine.

Re:Interesting side effects (2, Informative)

Baloroth (2370816) | more than 2 years ago | (#40818861)

Not necessarily. This is a court decision, not a new statutory law. A significant (very very very significant) part of the job of a court is to decide over specific cases and whether the law, in word and in spirit, is supposed to apply to that case. They ruled that in this case (stem cells) it does. In the case of dialysis, they might not (probably wouldn't, since it is a proven long-standing and genuinely routine medical procedure). It is a very fine line, but that is what the courts are for: so that they can walk that line, and the legislature doesn't have to (of course, the legislature often does, but that is a different problem).

Re:Interesting side effects (-1, Troll)

roman_mir (125474) | more than 2 years ago | (#40819137)

yeah, except the 'very specific' cases in the hands of the government become general powers, and who and what army is going to stop the government from taking a decision of a court that is based on a very limited and specific set of circumstances and using it to cover all general cases?

That's the reason the personal income taxes are collected by the IRS. Personal income taxes are illegal and are collected illegally, the court cases regarding income taxes ruled that the 16th amendment only allows the government to collect taxes from corporate profits, not from anything remotely similar to 'personal income', you can see the journal entry that I am linking to in my sig to get more information on it.

The person who was trying to make that argument to the courts in USA has served 3 sentences and is now serving his 4th, it's a 13 year sentence handed out to a 78 y.o. guy, who is now 84, and the judge never allowed his arguments to be heard by the jury, it's not hard to guess why the jury wasn't allowed to listen to the arguments in the case. [youtube.com]

Re:Interesting side effects (0)

Anonymous Coward | more than 2 years ago | (#40819435)

the court cases regarding income taxes ruled that the 16th amendment only allows the government to collect taxes from corporate profits, not from anything remotely similar to 'personal income', you can see the journal entry that I am linking to in my sig to get more information on it.

So what, now corporations are people and humans are not or something? The amendment says nothing at all about corporations. In fact it says

The Congress shall have power to lay and collect taxes on incomes, from whatever source derived, without apportionment among the several States, and without regard to any census or enumeration

I'd say that "from whatever source derived" pretty much covers everything.

Re:Interesting side effects (0)

roman_mir (125474) | more than 2 years ago | (#40819689)

Again, you can argue against your own straw figurines or you can follow the link, read about the income taxes in it.

The SCOTUS decided on more than one occasion that the 16th amendment means the following: it's not the people, who are allowed to be taxed, it's income that can be taxed ONLY if it can be separated from its source, so it cannot be tied to a person directly, because all direct taxes must be apportioned, (the 16th amendment doesn't change the fact that all direct taxes must be apportioned).

The SCOTUS explained that the way to separate the source from income is through a corporate balance sheet! There so called 'income' tax is only legal when it applies to a balance sheet, what is allowed to be taxed is the difference between revenues and expenses, commonly known as PROFIT.

The income tax, by the SCOTUS, is only legal if it is actually narrowly applied as a tax on profits. (Incidentally individuals do not have profits, they have incomes, corporations have profits).

The government is collecting the personal income taxes illegally, it widened the narrow ruling of the SCOTUS unilaterally.

Re:Interesting side effects (1)

h4rr4r (612664) | more than 2 years ago | (#40820015)

I suggest you test out that theory. Call up the IRS and tell them all about your plan to not pay. See how it works out.

Re:Interesting side effects (2)

dgatwood (11270) | more than 2 years ago | (#40818885)

But it is none the less weird that if dialysis was invented today, it would be considered a drug under than doctrine.

Not really. Any time you're connecting a device into somebody's veins or putting liquids into somebody's chest cavity, the government should regulate the safety and efficacy of the treatment. It's not like we're talking about foot massages here....

Re:Interesting side effects (2)

jbeaupre (752124) | more than 2 years ago | (#40818955)

Dialysis was already governed by the FDA as a device and through drug regulations. The machines are devices, the dialysate is a chemical formulation.

I'm trying really hard not to call you a dumbass. Yes, I will take the higher ground and not call you a dumbass.

Re:Interesting side effects (3, Informative)

Trepidity (597) | more than 2 years ago | (#40818979)

A number of doctors do think dialysis should be better regulated than it is now, to ensure that patients are getting actually good care following scientifically validated practices. The two options are basically to regulate it as a drug, or as a medical device [thekidneydoctor.org] .

Everything (0)

Dan East (318230) | more than 2 years ago | (#40818729)

Everything in existence can have a biological effect. Thus everything is a drug. Thus the FDA can regulate everything.

Re:Everything (5, Insightful)

MozeeToby (1163751) | more than 2 years ago | (#40818803)

Injecting stem cells randomly into the body is probably not a good idea. Stem cells aren't magically fix everything machines. There's a significant risk of cancer if nothing else and I'd be shocked if there weren't other potential issues as well. Why do we have people running around defending hack doctor's rights to inject them on unsuspecting and uninformed patients? And don't say the patients are informed, the research on risks hasn't even been completed yet, how could they possibly be informed of risks that the administering doctor doesn't even know about?

Lets go to an extreme, how would you feel about the FDA telling a doctor that they can't inject stomach acid into a person's blood stream? Other than the risks being more obvious, what's the difference?

Re:Everything (1)

cayenne8 (626475) | more than 2 years ago | (#40819391)

Why do we have people running around defending hack doctor's rights to inject them on unsuspecting and uninformed patients?

Because, largely, it is not a bunch of hack doctors doing this....I know some very reputable physicians, that are getting some amazing results from this, and since it is your own cells, not that much a problem with side effects.

And no...they don't just 'do' this to un-informed patients...they discuss it with them, risks/benefits...and have signed consent forms.

The majority of doctors out there are dedicated to helping people...their main job.

They'd have to be...with all the crap they have to put up with local hospitals, govt regulations, constant litigations by people trying to get rich quick...they'd have to love the job and be dedicated to it to stick with it.

You're not likely to be rich being a Dr like in the old days...

Re:Everything (1)

kenorland (2691677) | more than 2 years ago | (#40819957)

Injecting stem cells randomly into the body is probably not a good idea. Stem cells aren't magically fix everything machines. There's a significant risk of cancer if nothing else

Care to cite any studies/evidence?

Re:Everything (1)

macbeth66 (204889) | more than 2 years ago | (#40818823)

Yes, as they should if that 'everything' is claimed to have medicinal value.

That is their mandate. Whether or not the FDA does things the right way is another story.

Re:Everything (2)

smooth wombat (796938) | more than 2 years ago | (#40818841)

Thus the FDA can regulate everything.

No, they can't. They can't regulate the homeopathic flim flam because it's not classified as a drug. Which it isn't.

The same thing with vitamins and supplements. Since they aren't classified as drugs, there is no regulation. No one knows what's in these things because the companies don't have to tell you what's in them. Testing has revealed that in most cases, sugar is the number one ingredient.

That's why homeopathic "medicine" isn't real medicine. They don't have to show their stuff works under standard, clinical trials and so get to fleece people of their money with miracle cures, ala Kevin Trudeau.

A rather logical move (4, Informative)

Schmorgluck (1293264) | more than 2 years ago | (#40818767)

Since one of the FDA's roles is to check medical treatments for safety and efficience, this is consistent with its mission.

Now it being able to do the job correctly is another matter entirely, regulatory capture seems to be the USA's national sport...

Re:A rather logical move (1)

nbetcher (973062) | more than 2 years ago | (#40818855)

Food and DRUG Administration. Enough said.

Re:A rather logical move (0)

Anonymous Coward | more than 2 years ago | (#40819533)

Well, yes. Enough to tell that you're a literal genie type who looks at superficial things and not details like the actually charter. They do sometimes contain more details.

If it really bothers you, consider the Department they're under. Health and Human Services.

Re:A rather logical move (0)

Anonymous Coward | more than 2 years ago | (#40819125)

The problem with having no revolving door is that you can end up with incompetent regulators who have no clue what they're doing.

Re:A rather logical move (0)

cayenne8 (626475) | more than 2 years ago | (#40819489)

Since one of the FDA's roles is to check medical treatments for safety and efficience, this is consistent with its mission.

Not really, the FDA is for Food and DRUGS....but they do not regulate medical procedures (they don't tell a Dr how to do surgery, lance a boil, give stitches...etc).

This is more a procedure than a drug...essentially taking your own stem cells out...isolating them, and then injecting them back into you. Does that strike you as a drug any more than having them take a vein out of your leg to use for your own heart bypass, or maybe sucking fat out of your ass, and injecting it into your lips or wherever else you need more 'fullness'?

Good thing?? (3, Insightful)

ZenDragon (1205104) | more than 2 years ago | (#40818829)

This doesn't really sound like a good thing. I understand the desire to want to regulate unproven stem cell therapies. However, if history has shown us anything it is not regulation that they seek, but to stifle the industry entirely. Likely so the large pharma stock holders can hold on to their dividends. Maybe I am understanding this wrong? Anybody with more understanding of the matter, feel free to enlighten me.

Re:Good thing?? (2, Informative)

Anonymous Coward | more than 2 years ago | (#40819261)

The core concept here is that the treatments in question have not demonstrated that they:
1. Are effective at treating the maladies for which they are prescribed.
2. Are not likely to cause side effects that aren't well understood.
3. Have disclosed all known risks to the patients prior to administering treatment.

The FDA is the agency tasked with ensuring that medical treatments comply with those requirements. They were founded because the free market will left to it's own devices favor snake-oil salesmen who sell "miracle cures" that are cheap to make required no R&D (because they don't actually work) and are marketed as having vague health benefits so as to side-step advertising fraud legislation. Think "head on (apply directly to the forehead)", only in "injecting stuff into your bloodstream" form.

Re:Good thing?? (1)

the eric conspiracy (20178) | more than 2 years ago | (#40819693)

Even if sale of these treatments was not regulated there is the issue of how someone is supposed to make a rational decision as to what the effectiveness and dangers of the treatment are, and a process for validating the ongoing quality of the products being used.

Right? (3, Insightful)

J'raxis (248192) | more than 2 years ago | (#40818919)

The FDA [eprci.net] , a government bureaucracy, has "rights"?

Re:Right? (1)

Schmorgluck (1293264) | more than 2 years ago | (#40819283)

Ah, well spotted... This wording is indeed problematic. Government bodies have no rights, only missions, and anything that isn't part of their missions is forbidden to them.

Re:Right? (1)

CptNerd (455084) | more than 2 years ago | (#40819359)

That's outmoded 18th Century thinking, we're so much more evolved now, and our Living Constitution needs to be rethought in this new age, with so many more smart people in government. Why, the intellectual capacity of 500+ Legislators, not to mention the tens of thousands of bureaucrats, is surely wiser than the handful of technologically ignorant Founders...

Re:Right? (1)

the eric conspiracy (20178) | more than 2 years ago | (#40819643)

A constitution is not the act of a government, but of a people constituting a government; and government without a constitution is power without a right. All power exercised over a nation, must have some beginning. It must be either delegated, or assumed. There are not other sources. All delegated power is trust, and all assumed power is usurpation. Time does not alter the nature and quality of either.

-Thomas Paine.

Equal time (1)

Empiric (675968) | more than 2 years ago | (#40818937)

Government-encroaching Luddite religion suppressing science and freedom!

How'd I do?

Or, maybe it's just a good idea to have some sort of vetting process before people start mass-injecting biological material into themselves.

It's about time (2, Insightful)

drunken_boxer777 (985820) | more than 2 years ago | (#40818997)

But perhaps it is too little too late. There are dozens, if not hundrends of these clinics set up outside the US. Many are in Asia or islands in the Caribbean/Atlantic. Who knows how many people have been defrauded.

On the other hand, some of these shops might have reason to believe that stem cells only need to be extracted and applied to do their work. Jenner's small pox "vaccine" was just ground up scabs that he rubbed into a cut that he made in the patient's arm. Ridiculously crude by today's standards. But it worked. So perhaps (in their minds) some of these stem cell treatments could have merit.

But I don't think that is likely the case. Applied stem cell biology is quite complex, particularly since the body tries to keep stem cells from becoming cancer. In humans, it is more of an issue because we reproduce relatively later in life and rear our young for far longer than most animals. In other creatures, like newts, it is less of an issue and they can regenerate entire limbs.

Nearly all of these companies are probably well aware of how unlikely it is their treatment will help anyone, but can't say no to the truckloads of money. They don't want to perform the science that will lead to stem cell cures, and go after the crude "Jenner" method. The problem is that medical science has advanced significantly since the 18th century and conditions like joint pain don't exactly warrant unproven treatments in the same way that certain cancers might.

I, for one, look forward to the FDA shutting these operations down.

Re:It's about time (2)

kimvette (919543) | more than 2 years ago | (#40819379)

conditions like joint pain don't exactly warrant unproven treatments in the same way that certain cancers might.

Right, right. It's better to put someone on opiates to manage the pain and send them driving home, or to inject them with cortizone and cause them to bloat up - and if the patient is female to develop hirsutism. Yes, it's far better to do that than to try something which has a very high potential of actually rebuilding the cartilage.

Re:It's about time (1)

h4rr4r (612664) | more than 2 years ago | (#40819993)

How do we know it has a high potential of doing that?

Please show us the studies. What we have instead is you suggesting we try random untested procedures instead of pain management that we know works. I would imagine the risk of unsightly hair is more manageable for the patient than a totally unknown outcome for what may well be no actual improvement at all.

Re:It's about time (2)

randallman (605329) | more than 2 years ago | (#40819501)

The theory of how this works is that it is a purified version of microfracture [wikipedia.org] , which is now prevalent (especially among athletes) and accepted. Microfrature works because the stems cells from the bone marrow form new cartilage, which produces hyaline cartilage material, but also lots of stuff you don't want, making the result inferior to pure hyaline cartilage (called fibrocartilage). So in theory, if you remove the crap (isolate the stem cells), you can get a more pure cartilage formation.

It makes sense and Regenerative Sciences is claiming something like an 80% success rate. Microfrature was controversial at its infancy, but the results spoke for themselves and the sports industry took notice and became early adopters. A similar thing is happening now with stem cell therapy as athletes have taken notice (Bartolo Colón, Jarvis Green). I've been watching Regenerative Sciences for 3-4 years looking for the negative reports to come on (fraud, etc) and haven't seen them. Instead I've seen them rise in popularity, branching out and publishing (results as well as safety and complication data). They're claiming very good results and behaving responsibly as far as I can tell.

Re:It's about time (1)

Nexus7 (2919) | more than 2 years ago | (#40819703)

You said:
"Applied stem cell biology is quite complex,..."

That is the key here. You think it is complex, but looking at the postings above yours, and at least one followup to it, people are thinking that the FDA, scientists, the whole edumacationistic cabal, are making things too complex to preserve their authority. See for example, postings saying there's enough information out there that people can come to their own conclusions and decide for themselves. See how anti-vaccine kooks get copious air-time (any kooks, for that matter) - just because they can't see why the FDA is correct must mean the FDA is wrong.

And there's also this anti-government/libertarian sentiment (why do we need medical regulation, why do we need the dept of education, etc.). In some cases, there is over-regulation and some times regulation does lead to beneficial drugs getting to market later than otherwise, but the FDA exists because the record of the free market in medicine has only debilitating injury and death to show for it.

And I think we're finding this out with there off-shore stem cell facilities too. Only the failures never make it to the marketing material, so these treatments always work, so why should the FDA not let everyone get the benefit, right?

Big brother knows best ? (0)

Anonymous Coward | more than 2 years ago | (#40819017)

Experience proves otherwise.

But in the end, people get the government they deserve.

Look around you, if you live in the US, and what do you see ?

If you are honest, you must admit that you see a vast ocean of human waste.

Wat? (5, Funny)

Quiet_Desperation (858215) | more than 2 years ago | (#40819055)

Quick! I need an ideological purist to tell me what to think about this!

Re:Wat? (1)

Anonymous Coward | more than 2 years ago | (#40819327)

Quick! I need an ideological purist to tell me what to think about this!

As a Free Thinker, I can only advise you to educate yourself as best you can and come to your own (possibly incorrect) conclusions. Sorry.

Re:Wat? (1)

dkleinsc (563838) | more than 2 years ago | (#40819515)

You should love/hate this without doing anything to analyze it, of course!

Re:Wat? (0)

Anonymous Coward | more than 2 years ago | (#40819543)

You've come to the right place.

Re:Wat? (0)

Anonymous Coward | more than 2 years ago | (#40819601)

Magic Eight Ball says, "Reply hazy, try again".

This is what Kobe an many other athletes have done (1)

danparker276 (1604251) | more than 2 years ago | (#40819661)

Regenexx is doing what many athletes are doing to their knees or shoulders to repair cartilage. A lot of athletes including Kobe have done a lot better because of this. They'll be the guinea pigs I guess.

Basic truth: most new drugs don't work (1)

Animats (122034) | more than 2 years ago | (#40819735)

The FDA's job is to require that drugs are "safe and effective". Most new drugs fail those tests during the development process. Some work in test tubes, but not in animals. Some work in animals, but not in humans. Some are unsafe for some fraction of the population. Some look useful in humans at first, but a few years downstream, haven't improved health or survival rates. Only about 13% of small-molecule drugs, and 32% of large-molecule drugs that start phase 1 clinical testing make it to actual use.

This is why there's a need for so much clinical testing, data collection, and feedback. Without that, nobody knows what really works, and there's no forward progress.

Healthcare a right? (1)

snsh (968808) | more than 2 years ago | (#40819855)

The "right to healthcare" officially does not exist as long as government can totally block you from getting the treatment you want.

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